Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder

NCT ID: NCT07226661

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-01-31

Brief Summary

This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of SPN-821 administered twice a week as adjunctive therapy to an approved antidepressant therapy in adult participants with MDD. The study includes a 2-week Screening Period, a 4-week Double blind Treatment Period, and a Safety Follow-up phone call one week after the completion of the Treatment Period.

Conditions

Major Depressive Disorder (MDD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SPN-821 2400 mg

Three 800 mg oral tablets administered twice a week adjunctive to current antidepressant

Group Type: EXPERIMENTAL

SPN-821 2400 mg

Intervention Type: DRUG

SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling

Placebo

Three oral tablets administered twice a week adjunctive to current antidepressant

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo oral tablets

Interventions

SPN-821 2400 mg

SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling

Intervention Type: DRUG

Placebo

Matched placebo oral tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Current diagnosis of MDD according to the DSM-5 for either single or recurrent MDE without psychotic features confirmed by the MINI
• Duration of current MDE of at least 8 weeks
• MADRS total score of ≥ 24 at the Screening Visit and Day 1 Visit
• CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit and Day 1 Visit
• Stable, therapeutic dose of one of the following protocol-approved ADTs as a monotherapy for ≥ 8 weeks before the Screening Visit and ≥ 10 weeks at the Day 1 Visit. Additionally, inadequate response to the current ADT (less than 50% improvement in depressive symptoms) as confirmed by the ATRQ Investigator administered.

Exclusion Criteria

• MADRS total score change of ≥ 25% from the Screening Visit to Day 1 Visit
• History of treatment resistant depression (TRD) defined as 3 or more failed ADTs of adequate dose (per ATRQ) and duration (at least 8 weeks) for the current MDE
• History of alcohol or substance use disorder according to DSM-5 criteria 6 months before the Screening Visit
• Evidence of significant risk for suicidal behavior during participation in the study in the Investigator's opinion
• Lifetime diagnosis of any psychotic disorder including MDD with psychosis, MDD with mixed features, bipolar I/II disorder, bipolar depression, schizophrenia, posttraumatic stress disorder, autism spectrum disorder, or any personality disorder or intellectual disability that would affect the ability of the participant to enroll in the study
• Diagnosis less then 12 months before screening of severe obsessive-compulsive disorder, acute stress disorder, panic disorder, eating disorders, or any other psychiatric condition that has been the primary focus of treatment, or diagnosis of generalized anxiety disorder less then 6 months before screening.
• History of cardiovascular, respiratory, gastrointestinal, renal, hepatic, and hematologic disorders, or other medical disorders that could impose undue risk or compromise the study in the Investigator's opinion
• Clinically significant abnormal result prior to Day 1 Visit per Investigator's judgment or abnormal renal function.
• Requires treatment with a medication or other substance that is prohibited by the protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Collaborative Neuroscience Network

Garden Grove, California, United States

Countries

United States

Central Contacts

Gianpiera Ceresoli-Borroni, PhD

Role: CONTACT

Phone: 301-838-2521

Email: gceresoliborroni@supernus.com

Other Identifiers

821P203

Identifier Type: -

Identifier Source: org_study_id